Cardiothoracic Systems, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cardiothoracic Systems, Inc.” (first 1997, latest 2001), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 198 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXC | Clamp, Vascular | 3 | 3 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
| FQH | Lavage, Jet | 1 | 1 |
| MWS | Stabilizer, Heart | 1 | 1 |
Review panels
Most recent Cardiothoracic Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K010117 | GUIDANT AXIUS CORONARY SHUNT | DXC | 2001-04-04 | 78 |
| K983270 | VOYAGER QUAD CANNULA | DWF | 1999-07-28 | 314 |
| K982419 | HEART-LIFT BALLOON POSITIONER | MWS | 1999-01-13 | 184 |
| K983135 | BLOWER/MISTER | FQH | 1998-11-13 | 66 |
| K963965 | CTS MIDCAB STITCHER | GEI | 1998-03-17 | 531 |
| K970638 | CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT | DXC | 1997-10-30 | 252 |
| K963503 | CTS MIDCAB CORONARY SHUNT | DXC | 1997-04-03 | 212 |
| K963930 | CTS MIDCAB/SVH BIPOLAR SCISSORS | GEI | 1997-01-16 | 107 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiothoracic Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiothoracic Systems, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Cardiothoracic Systems, Inc.” (first 1997, latest 2001), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiothoracic Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiothoracic Systems, Inc. is 198 days.
Which FDA product codes appear under Cardiothoracic Systems, Inc.?
The most frequent FDA product codes under this applicant name are DXC (Clamp, Vascular, 3); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 8 Cardiothoracic Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXC, Cardiothoracic Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.